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510(k) Data Aggregation
K Number
K992258Device Name
HOT SHOT FLUID WARMER IV FLUIDSManufacturer
Date Cleared
2000-01-12
(190 days)
Product Code
Regulation Number
N/AType
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
INFRA-MED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Warm intravenous fluids.
Device Description
HOT SHOT™ FLUID WARMER IV FLUIDS
AI/ML Overview
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Hot Shot™ Fluid Warmer IV Fluids." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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